Home > Pill Identifier > APAP 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet

Pill Identifier Information of APAP 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet

Drug Information

APAP 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet

Imprint: 44;526
Shape: C48336
Color: C48325
Ingredients: Acetaminophen; Diphenhydramine; Phenylephrine
Size: 17.00
Score: 1
Rxtty: SY
Author: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Inactive Ingredients: Starch, Corn / Croscarmellose Sodium / Magnesium Stearate / Cellulose, Microcrystalline / Polyethylene Glycol / Polyvinyl Alcohol / Povidone / Silicon Dioxide / Stearic Acid / Talc / Titanium Dioxide>

Complete Information

  • Drug Facts

  • Active ingredients

    (in each caplet)

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms of the common cold:
    • runny nose
    • sneezing
    • headache
    • minor aches and pains
    • nasal congestion
    • cough
    • sore throat
    • temporarily reduces fever
  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if:

    • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours
    • taking with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, condult a doctor promptly.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an MAOI, ask a doctor or pharmacist before taking this product.
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if the user has

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a cough accompanied by too much phlegm (mucus)
    • a persistant or chronic cough such as occurs with smoking, asthma, or emphysema
    • a breathing problem such as emphysema or chronic bronchitis
  • Ask a doctor or pharmacist before use if the user is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • When using this product

  • Stop use and ask a doctor if

    These could be signs of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centrer right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years and over

    take 2 caplets every 4 hours

    do not take more than 12 caplets in 24 hours
    children 6 to under 12 years of age

    take one caplet every 4 hours

    do not take more than 5 caplets in 24 hours
    children under 6 years of agedo not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

  • Inactive ingredients

    corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    CVS®

    pharmacy

    Compare to the active ingredients in

    Sudafed PE® Severe Cold*

    See New Warnings Information

    SEVERE

    COLD RELIEF PE

    MULTI-SYMPTOM

    ACETAMINOPHEN,

    DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

    PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE

    COUGH SUPPRESSANT, NASAL DECONGESTANT

    ● Nasal & Sinus Congestion

    ● Fever & Body Aches

    ● Cough & Sore Throat

    Does not contain Pseudoephedrine

    24 COATED CAPLETS

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    50844           REV1209B52608

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2010 CVS/pharmacy

    www.cvs.com

    1-800-shop-CVS

    Product Label
  • INGREDIENTS AND APPEARANCE
    SEVERE COLD RELIEF PE  
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-526
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Polyvinyl Alcohol (UNII: 532B59J990)  
    Povidone (UNII: FZ989GH94E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 44;526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-526-021 in 1 CARTON
    112 in 1 BLISTER PACK
    2NDC:59779-526-081 in 1 CARTON
    224 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/21/2005
    Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Registrant - L.N.K. International, Inc. (832867837)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.N.K. International, Inc832867894MANUFACTURE